{"id":10831,"date":"2017-03-12T08:00:50","date_gmt":"2017-03-12T08:00:50","guid":{"rendered":"http:\/\/www.viamedic.com\/blog\/?p=3422"},"modified":"2017-03-12T08:00:50","modified_gmt":"2017-03-12T08:00:50","slug":"will-the-female-viagra-experience-change-how-the-fda-approves-drugs","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/current-health-news\/will-the-female-viagra-experience-change-how-the-fda-approves-drugs\/","title":{"rendered":"Will the ‘Female Viagra’ Experience Change How the FDA Approves Drugs?"},"content":{"rendered":"

\"Female
The FDA is under scrutiny for its approval of certain drugs, like Addyi, which had questionable effectiveness and side effects.<\/figcaption><\/figure> Recently, two drug manufacturers, who had developed two very different kinds of drugs, pushed the FDA for approval \u2013 and got it.\u00a0<\/p>\n

Female sexual arousal disorder and Duchenne muscular dystrophy (DMD) do not have anything in common \u2013 except that recent FDA-approved drugs to treat these conditions are under scrutiny.\u00a0Some medical experts are saying that the FDA succumbed to the public pressure put on them and that the review process must be revised.<\/p>\n

The Drugs that Shook Up the FDA Approval Process<\/strong><\/p>\n

FDA scientists thought studies designed to test the safety of Exondys 51, the drug that is now prescribed to treat \u00a0Duchenne Muscular Dystrophy (DMD), was\u00a0flawed in determining the risk of side effects and overall effectiveness.\u00a0<\/p>\n

Addyi, the \u201csometimes called female Viagra\u201d was actually rejected by the FDA in 2010 and 2013 and the National Women’s Health Network also gave the drug<\/a> “D”s, “F”s and “I”s–for “incomplete”–on a report card assessing its first-year performance.\u00a0<\/p>\n

But, in contrast, many women who suffer from low libido claim that taking FDA approved Addyi, also called \u201cthe little pink pill,\u201d provided notable improvement to their levels of sexual desire. Despite the patient accolades,\u00a0some studies<\/a>\u00a0suggest that improvements from taking the medication were minimal.<\/p>\n

Now, the approval of these drugs and the questions surrounding their safety versus their value to a patient\u2019s health is raising concerns about the FDA. The argument suggests that public pressure, versus strong scientific evidence, is behind some medications hitting the market. This has put the FDA approval process under scrutiny<\/a> and changes may be forthcoming.<\/p>\n

A Closer Look at the FDA<\/strong><\/p>\n

The FDA has taken a closer look at their approval process. It recently drafted a 15-page “draft guidance<\/a>” on developing drugs for the treatment of “low sexual interest, desire and\/or arousal in women.”\u00a0<\/p>\n

Cindy Pearson, executive director of the National Women’s Health Network in Washington, D.C., who previously disapproved of the release<\/a> of Addyi because of questions about effectiveness the risks it posed to those taking it, stated that this is a positive step though it is coming a little too late.<\/p>\n

Two recent documents posted to the Food and Drug Administration’s website suggested that the FDA approval process responds to the pleas of patients with female sexual dysfunction and DMD, rather than scientific evidence of effectiveness and safety. If true, the approval process is flawed.<\/p>\n

A Closer Look at the Conditions and the Drugs<\/strong><\/p>\n

The two conditions in the spotlight have nothing in common \u2013 one is a genetic disease that typically affects boys, causing muscles to deteriorate over time until they die, usually before the age of 30, while the other is a psychiatric diagnosis<\/a> in women who suffer low libido with no known medical cause.<\/p>\n

And Addyi has had its share of concerns in the treatment of female sexual dysfunction. This year, a review of clinical trials<\/a> concluded that the drug on average resulted in one additional \u201csatisfying sexual event\u201d every two months, but also \u201cstatistically and clinically significantly increasing the risk of dizziness, somnolence, nausea and fatigue.\u201d<\/p>\n

One study, conducted by a team of Dutch researchers, examined a group of eight separate studies combined, which included the results of about 6,000 women who took Addyi for low libido. The results indicated that Addyi, or flibanserin<\/a>, provided only a minimal change in the libido of women within their study.\u00a0<\/p>\n

Some argue that those studies are flawed. Medical director of the Center for Sexual Medicine at Northwestern Memorial Hospital in Chicago, Dr. Lauren Streicher, told CNN that the results cited in the Dutch study are based only on averages.\u00a0<\/p>\n

This means that while it may be true that Addyi doesn’t work for everyone, many patients, including several Dr. Streicher has prescribed Addyi to, have found it to be very beneficial.<\/p>\n

As for the drug Exondys 51, in the FDA review process for approval, only three of 13 members of an advisory committee agreed that the scientific evidence showed it to be effective.\u00a0<\/p>\n

Sarepta Therapeutics, maker of the drug, had apparently conducted a trial of the drug with only 12 participants. The findings showed some minimal, positive lab changes with its use, but the results did not match the patient\u2019s physical disabilities with walking, for example.<\/p>\n

However, faced with heartbreaking testimony from 52 patients, parents, advocates, scientists and lawmakers–all but one urging approval of Exondys 51, the drug gained FDA approval.<\/p>\n

Revamping the FDA Approval Process\u00a0<\/strong><\/p>\n

The FDA is poised for changes. For example, the agency will probably do more to insist that sponsors follow their advice earlier in the research process. Recommendations, like using a larger sample and controls (patients who received a placebo for comparison purposes), within clinical trials are in order.<\/p>\n

Four main points made for the future of drug approval from the FDA:\u00a0<\/p>\n